Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer (ExteNET)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Puma Biotechnology, Inc.

ClinicalTrials.gov Identifier:

NCT00878709

First received: April 8, 2009

Last updated: June 27, 2017

Last verified: June 2017

History of Changes

Purpose

The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

Condition	Intervention	Phase
Breast Cancer	Drug: neratinib Other: placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Trastuzumab Neratinib

U.S. FDA Resources

Further study details as provided by Puma Biotechnology, Inc.:

Primary Outcome Measures:

disease free survival (DFS) [ Time Frame: Two years ]

Secondary Outcome Measures:

Time to Distant Recurrence (TTDR) [ Time Frame: Two through Five years ]
The time between randomization and the date of the first distant recurrence, or death from breast cancer
Disease free survival including ductal carcinoma in situ (DFS-DCIS) [ Time Frame: Two through Five years ]
The time from randomization to the first occurrence of any DFS event or DCIS
Distant disease free survival (DDFS) [ Time Frame: Two through Five years ]
The time from randomization to the first distant recurrence or death from any cause.
Incidence of central nervous system recurrence [ Time Frame: Two through Five years ]
Overall survival [ Time Frame: Ten years ]
Short and long term safety of neratinib [ Time Frame: Thirteen months ]
disease free survival (DFS) [ Time Frame: Five years ]


Enrollment:	2840
Actual Study Start Date:	July 9, 2009
Estimated Study Completion Date:	November 2020
Primary Completion Date:	August 21, 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: neratinib 240 mg orally daily for 1 year Other Name: HKI-272
Placebo Comparator: 2	Other: placebo orally daily for 1 year

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
Been treated for early breast cancer with standard of care duration of trastuzumab.
Could have been treated neoadjuvantly but have not reached pCR.

Exclusion Criteria:

Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
History of heart disease.
QTc interval >0.45 seconds
History of gastrointestinal disease with diarrhea as the major symptom.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878709

Show 493 Study Locations

Sponsors and Collaborators

Puma Biotechnology, Inc.

Investigators


Study Director:	Puma	Biotechnology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chan A, Delaloge S, Holmes FA, Moy B, Iwata H, Harvey VJ, Robert NJ, Silovski T, Gokmen E, von Minckwitz G, Ejlertsen B, Chia SK, Mansi J, Barrios CH, Gnant M, Buyse M, Gore I, Smith J 2nd, Harker G, Masuda N, Petrakova K, Zotano AG, Iannotti N, Rodriguez G, Tassone P, Wong A, Bryce R, Ye Y, Yao B, Martin M; ExteNET Study Group. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):367-77. doi: 10.1016/S1470-2045(15)00551-3. Epub 2016 Feb 10.


Responsible Party:	Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:	NCT00878709 History of Changes
Other Study ID Numbers:	3144A2-3004 B1891004
Study First Received:	April 8, 2009
Last Updated:	June 27, 2017


Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Puma Biotechnology, Inc.:


HER-2/erbB-2 positive breast cancer breast cancer adjuvant therapy neratinib HKI-272

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases	Skin Diseases Trastuzumab Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2017

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